Qualification Specialist

Overview BSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxic characteristics for the Pharmaceuticals Industry. BSP has been at the forefront in the fight against cancer since 2006. Innovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant. We are one of the most important Contract Development and Manufacturing Organizations (CDMOs) for anticancer drugs. The fight against cancer is ours too. Position We are currently looking for a Qualification Specialist - that will mainly ensure: Main Activities Analysis of technical documentation related to equipment and utilities to be qualified, to acquire information necessary for the definition of protocols and the execution of qualification activities in compliance with company procedures Definition of qualification documents, by drafting documents such as Risk Assessments, DQ/IQ/OQ/PQ Protocols, Validation Master Plan, Validation Plan, and Project Qualification Plan, obtaining data from other functions to define contents and qualification strategy Qualification: within the required time frame, perform proper qualification of equipment and utilities through the execution of activities specified in the Protocols (DQ-IQ-OQ-PQ). In collaboration with Purchasing, formulate bid requests to suppliers and support the Manager with technical and economic bid analyses Qualification Reports: properly prepare Qualification Reports (DQ/IQ/OQ/PQ) based on data from validation activities in compliance with company protocols and procedures Requisiti Main Requirements Master's Degree in Chemical Engineering/CTF/Chemistry Knowledge of regulations regarding Equipment and Utilities validation, with particular reference to sterile departments At least 2 years of experience in the same role in complex organizations English Can-do attitude Altre informazioni At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity, the different backgrounds and experiences and provide equal opportunity for all. We are BSP. J-18808-Ljbffr

Location: Latina, Lazio, IT

Posted Date: 9/17/2025